My involvement in this trial started in late 2017. I had just had a baby and come back to work as a neurology registrar in Addenbrookes hospital in Cambridge. As part of my training to become a neurology consultant, I was planning on embarking on a PhD. I’d previously done a small amount of research in PD in Newcastle whilst I was a medical student, and I’d emailed Prof Roger Barker looking for a clinical project that I could get involved in. He put me in touch with Caroline. It feels like I’ve had a long road to get here, but Caroline’s is much longer. By the time I came on-board she had come up with the concept, designed the trial and successfully secured funding through the Centre for Parkinson’s Plus. (Naively) at that point it felt that the majority of the large hurdles were cleared. I started at the John van Geest Centre for Brain Repair in January 2018, working on writing the protocol and associated documents that accompany the running of a clinical trial, and preparing the application for the Research Ethics Committee. We thought we would be recruiting patients by the end of that year…
It’s year three, another baby and one pandemic later. But we are here. On the brink of welcoming our first participants to AZA-PD. (Fingers crossed for no further hiccups!).
Today I confirmed our first official participant! It’s taken longer than I imagined to get underway. So far, I’ve sent invitations to 40 people, and 11 have signed up for screening to determine if they’re eligible. I have to follow a process of sending information sheets out to people who have consented through our research clinic, then waiting two weeks, before following up with a phone call. I can then book people who are interested in for a “screening visit”. This is where I meet people face-to-face and we go through checks to see if they formally meet criteria to enter the trial. As you can imagine, we have to be very strict with these checks, as our approval by the research ethics committee relies on us following the pre-written protocol word for word.
When I’m ringing people, I almost miss lockdown, when you could be sure that people would be at home and would answer their phone! But once I get through, everyone has been so open to talking with me. There’s been a whole range of responses including “when can I sign up!” which always makes me really excited. And despite planning this for the last three years, I’ve been asked questions I hadn’t thought of. It’s good to be kept on your toes.
One of the hardest things that I’ve found is finding the balance between optimism and realism when talking to potential participants. I’ve been trying very hard not to promise things that we can’t guarantee, but I had a colleague sit in whilst I was talking to a potential participant the other day, and he commented that I could be a little more positive! It’s true, we don’t know for sure that azathioprine is going to slow Parkinson’s disease down (which of course is why we’re doing the trial), but there’s lots of evidence to suggest that it will. We are asking people to give up a lot of their time to be part of their trial, and I’m relying on a huge amount of altruism on the part of our patients. However, there is a half chance that they will be getting active treatment and will get a personal benefit. Plus I’m planning to make the visits as enjoyable as possible!
My challenge today was trying to coordinate getting my first prospective participant into the scanner for a PET/MRI before they enter the trial. I had to confirm that they were eligible and had passed screening by getting the results of a blood test- TPMT, which had been shipped to Birmingham for analysis. Foolishly, I thought I knew which hospital lab it had got sent to. I ended up ringing three, before getting to the right one, and was then on hold for the best part of an hour. But I got the result! This was brilliant, because it meant that I made the deadline to confirm the PET/MRI appointment for next week. We’re on a really strict timeline to make sure I follow everything as per the pre-defined protocol. What was most frustrating was the fact that the blood result had been ready for a week, and only took 2 days to process. It seems the only delay is one lab emailing another one.
The next exciting milestone is the first “baseline” trial visit for this participant, happening in two weeks’ time. This is where they will receive a pot of the trial medication (placebo or azathioprine)…